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Completed

NCT Number: NCT02307461

Bioequivalence of Duvelisib and Food Effect on Pharmacokinetics of IPI-145

To Evaluate the Bioequivalence of the two formulations of IPI-145 and the Effect of Food on the Pharmacokinetics of IPI-145

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lenexa, Kansas, 66219, United States

About this study

This Phase 1, randomized, open-label study of IPI-145 will be conducted in 2 parts.

Part 1 will be conducted in 2 cohorts. Cohort 1 will consist of 32 healthy subjects, and Cohort 2 will consist of 52 healthy subjects. Subjects in each cohort will receive 2 doses of IPI under fasted conditions in a 2-period, 2-sequence crossover design. Dosing in Period 1 and Period 2 will be separated by at least 7 days.

Part 2 is a 2-period, 2-sequence crossover design to assess the effect of a high-fat meal on the PK of the IPI-145 in 20 subjects. Subjects will receive single oral doses under fed (high-fat meal) and fasted conditions, separated by at least 7 days.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men or women of non-child bearing potential between 18-50 years of age
  • Body Mass Index (BMI): 18.0 - 32.0 kg/m2.
  • Healthy subjects: in good health, determined by no clinically significant findings from clinical evaluations
  • Provided written informed consent prior to any study specific procedures

Exclusion criteria

  • Women of childbearing potential
  • Healthy subjects: positive screening test for hepatitis B surface antigen, hepatitis C antibody, or HIV-1/HIV-2 antibodies
  • ECG at screening showing QTcF ≥ 450 msec
  • Evidence of clinically significant medical conditions
  • History of gastrointestinal disease or surgery that may affect drug absorption
  • Positive T-Spot (tuberculosis)TB test at screening
  • Any active infection at the time of screening or admission

Treatment and study plan

IPI-145 (duvelisib)

Drug

High single oral dose capsule IPI-145 test formulation and IPI-145 reference formulation (capsule) high single oral dose

IPI-145

Drug

Low single oral dose capsule IPI-145 test formulation and IPI-145 reference formulation (capsule) low single oral dose

Primary outcomes

  1. Assessment of bioequivalence of the IPI-145 test and reference formulations

    Time frame: 24 Hours

  2. Pharmacokinetic Parameter (AUClast ) of IPI-145

    Time frame: Over 24 hours

  3. Pharmacokinetic Parameter (AUCinf ) of IPI-145

    Time frame: Over 24 hours

  4. Pharmacokinetic Parameter (Cmax) of IPI-145

    Time frame: Over 24 hours

Secondary outcomes

  1. Incidence of adverse events following administration of IPI-145

    Time frame: 7 weeks

Sponsors and collaborators

Lead sponsor

SecuraBio

Industry

Registry information

Official study title

A Phase 1, Open-label, 2-Part Study to Evaluate the Bioequivalence of the Duvelisib Marker-Image Formulation to the Duvelisib Clinical-Trial Formulation and to Assess the Effect of Food on the Pharmacokinetics of IP Duvelisib in Healthy Adult Subjects

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 4, 2014
Registry last updated
Mar 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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